NCT03548038

Brief Summary

It is commonly believed that a link exists between BMI and taste perception. One group of researchers observed that women who are obese experience reduced taste sensitivity when compared to normal-weight controls. Others have compared taste sensitivity between lean and obese subjects and found no significant differences. The inconsistencies in these studies demonstrate how much variation in taste sensitivity is possible when different factors are applied in research. Throughout several studies, one element remains constant - bariatric surgery causes appetite aversions. These changes in appetite and food preference likely have a large influence on the overall magnitude of post-surgical weight loss. Although many studies have investigated the changes in taste preference after bariatric surgery, few, if any, have focused on changes in sweet taste perception.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

May 24, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2020

Completed
Last Updated

November 2, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

May 24, 2018

Last Update Submit

October 29, 2020

Conditions

Taste, Altered

Keywords

taste perceptionbariatric surgerytaste preferenceweight loss surgery

Outcome Measures

Primary Outcomes (1)

  • Taste Perception on an Interval Scale

    Taste perception will be assessed by the subjects' responses to varying sucrose solutions. The interval scale begins with "barely detectable" at zero and goes up to "strongest imaginable" at 10. Subjects will be asked to draw an "X" at the location on the graph corresponding to their perception.

    Change from baseline to one month after bariatric surgery

Study Arms (1)

Bariatric surgery patients

All subjects will be patients scheduled for bariatric surgery. There is only one arm in this study.

Other: taste test

Interventions

taste testOTHER

All subjects will complete a procedure to determine their taste sensitivity to sweet tastants.

Bariatric surgery patients

Eligibility Criteria

Age21 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale subjects will be included.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women aged 21-70 will be recruited from the University of Missouri Bariatric Surgery Clinic.

You may qualify if:

  • Women who plan to undergo bariatric surgery.
  • Age: 21-70y.
  • Non-smokers (at least 3 months post smoking cessation).
  • Non-diabetic or prediabetic

You may not qualify if:

  • Subject on a medication known to affect taste perception: Antibiotics, thyroid medications, psychotropic, neurological, and cardiac medications.
  • Inability to understand the test instructions.
  • Subject has already undergone bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Elizabeth Parks

Columbia, Missouri, 65212, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (3)

  • Bueter M, Miras AD, Chichger H, Fenske W, Ghatei MA, Bloom SR, Unwin RJ, Lutz TA, Spector AC, le Roux CW. Alterations of sucrose preference after Roux-en-Y gastric bypass. Physiol Behav. 2011 Oct 24;104(5):709-21. doi: 10.1016/j.physbeh.2011.07.025. Epub 2011 Jul 30.

    PMID: 21827777BACKGROUND

  • Scruggs DM, Buffington C, Cowan GS Jr. Taste Acuity of the Morbidly Obese before and after Gastric Bypass Surgery. Obes Surg. 1994 Feb;4(1):24-28. doi: 10.1381/096089294765558854.

    PMID: 10742759BACKGROUND

  • Pepino MY, Finkbeiner S, Beauchamp GK, Mennella JA. Obese women have lower monosodium glutamate taste sensitivity and prefer higher concentrations than do normal-weight women. Obesity (Silver Spring). 2010 May;18(5):959-65. doi: 10.1038/oby.2009.493. Epub 2010 Jan 14.

    PMID: 20075854BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Before bariatric surgery, the subject will lightly scrape the inside of their cheek to harvest cells. These cell will be frozen for future DNA extraction and detection of taste receptor genes, T1R2 and T1R3.

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth J Parks, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 6, 2018

Study Start

May 24, 2018

Primary Completion

December 20, 2019

Study Completion

May 4, 2020

Last Updated

November 2, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)